Scorbolamid extra

Patient Information Leaflet

Scorbolamid EXTRA
300 mg + 200 mg + 50 mg + 5 mg, coated tablets
Salicylamide + Ascorbic acid + Rutoside + Zinc
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed
by a physician or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse, consult a doctor.

Table of Contents

1. What is Scorbolamid EXTRA and what is it used for
2. Important information before taking Scorbolamid EXTRA
3. How to take Scorbolamid EXTRA
4. Possible side effects
5. How to store Scorbolamid EXTRA
6. Contents of the pack and other information

1. What is Scorbolamid EXTRA and what is it used for

Scorbolamid EXTRA is a combination medicine with multiple actions:
Salicylamide – has antipyretic, analgesic and anti-inflammatory effects.
Ascorbic acid (vitamin C) – corrects vitamin C deficiency and supports the body's immune response during infections.
Rutoside – stimulates the immune system and supports the body during viral infections. It enhances the absorption of vitamin C and prolongs its action.
Zinc – corrects zinc deficiency and supports immune function.
Indications
Fever and symptoms associated with cold or flu, headache, immune system support in conditions of increased demand for vitamin C and zinc, and strengthening of capillary walls.

2. Important information before using Scorbolamid EXTRA

When not to use Scorbolamid EXTRA:

• if the patient is allergic to salicylamide, ascorbic acid, rutin, zinc, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to peanuts or soy, because the medicine contains soy lecithin;
• if the patient is allergic to non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has asthma with nasal polyps;
• if the patient has active peptic ulcer disease of the stomach and/or duodenum, and/or gastrointestinal inflammatory conditions;
• if the patient has acid-base balance disorders (e.g. diabetes, uremia, tetany);
• if the patient has blood coagulation disorders (e.g. hemophilia, thrombocytopenia);
• if the patient has genetically determined glucose-6-phosphate dehydrogenase deficiency;
• if the patient has kidney stones;
• if the patient has hemochromatosis (bronze diabetes), sideroblastic anemia, excess uric acid in the blood, or oxalates in the urine;
• if the patient has severe heart failure;
• if the patient is pregnant;
• if the patient is breastfeeding;
• if the patient is concurrently using methotrexate at doses of 15 mg per week or higher;
• in children and adolescents under 16 years of age (except for rare conditions such as Kawasaki disease), due to the risk of Reye's syndrome, a rare but serious illness causing liver and brain damage.

Warnings and precautions
Before starting treatment with Scorbolamid EXTRA, discuss it with your doctor or
pharmacist.
Exercise particular caution when using Scorbolamid EXTRA:

• if the patient has bronchial asthma;
• if the patient has liver or kidney impairment;
• in patients with a history of peptic ulcer disease or gastrointestinal bleeding;
• if the patient has hypertension.

Scorbolamid EXTRA and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, especially:

• medicines containing acetylsalicylic acid, or non-steroidal anti-inflammatory drugs (e.g. ibuprofen, diclofenac);
• corticosteroids, because salicylamide may exacerbate gastrointestinal adverse effects;
• oral antidiabetic agents, anticoagulants, valproic acid, sulfonamides;
• methotrexate at doses lower than 15 mg per week;
• digoxin, because salicylamide may enhance its effects;
• medicines used in gout;
• warfarin and fluphenazine, because ascorbic acid may reduce the effectiveness of warfarin and lower fluphenazine plasma concentrations;
• tetracyclines, copper- or iron-containing products, because zinc may reduce their absorption. The medicine should be taken at least two hours after administration of these compounds;
• antibacterial chemotherapeutic agents of the quinolone group, including fluoroquinolones, because zinc may reduce absorption of these products;
• folic acid, calcium and iron compounds, because they may reduce zinc absorption;
• penicillamine and other chelating agents. At least a 2-hour interval should be maintained between administration of penicillamine and zinc salts;
• thiazide diuretics, because they increase urinary excretion of zinc.

Scorbolamid EXTRA with food, drink and alcohol
See section 3.
Alcohol may intensify adverse effects.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy or breastfeeding.
This medicine belongs to a group of medicines that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
There is no information regarding contraindications for driving vehicles or operating machinery during treatment with this medicine.

Scorbolamid EXTRA contains tartrazine (E 102), sunset yellow FCF (E 110), and
soy lecithin (E 322)
This medicine may cause allergic reactions.
Do not use if hypersensitivity to peanuts or soy has been diagnosed.

3. How to use Scorbolamid EXTRA

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a physician or pharmacist. In case of doubt, consult a physician or pharmacist.

Adults and adolescents over 16 years of age:
Orally, 1 tablet 3 times daily.
It is best to take the medicine during a meal, with a glass of water.

Use the lowest effective dose. Symptomatic treatment without medical advice should be continued for the shortest possible time.

If symptoms do not improve within 3–5 days of treatment, or worsen (even before this time has elapsed), contact a physician as soon as possible.

Overdose of Scorbolamid EXTRA

In case of overdose, seek immediate medical advice.

Paracetamol (Acetaminophen)
Overdose of paracetamol may cause central nervous system depression, hypotension (low blood pressure), respiratory arrest, metabolic acidosis, or hypoprothrombinemia (deficiency of prothrombin in the blood).

Ascorbic acid
Symptoms of vitamin C overdose may include gastrointestinal disturbances such as diarrhea, vomiting, and heartburn, as well as skin flushing, headache, and insomnia. High doses may lead to hyperoxaluria and kidney stones. Daily doses of 600 mg may have a diuretic effect.

Rutoside
No cases of rutoside overdose have been reported.

Zinc
Symptoms of zinc overdose include burning pain in the mouth and throat, watery or bloody diarrhea, painful defecation, belching, hypotension (dizziness), jaundice (yellowing of eyes and skin), pulmonary edema (chest pain, difficulty breathing), and vomiting. Other possible symptoms include hematuria, anuria, collapse, seizures, and hemolysis.

In case of acute poisoning, induce vomiting. Then administer activated charcoal and provide symptomatic treatment, primarily involving fluid replacement.

Missed dose of Scorbolamid EXTRA

If a dose is missed, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions associated with salicylamide use
The most common adverse reactions affect the gastrointestinal tract and central nervous system.
These may include:

• nausea, vomiting, abdominal cramps, burning sensation behind the sternum, loss of appetite, diarrhoea, irritation of the gastric and duodenal mucosa (erosions and ulcers), dryness of the oral cavity. There has been no clear association observed between the use of salicylamide and gastrointestinal bleeding.
• dizziness, drowsiness, headache;
• z facial flushing, rash, excessive sweating.

This medicine should not be used in patients in whom acetylsalicylic acid or non-steroidal anti-inflammatory drugs have previously caused rash, angioedema (swelling of the face, tongue and airways causing breathing difficulties), bronchospasm, rhinitis or shock, as there is a possibility that these adverse reactions may occur after administration of Scorbolamid EXTRA.
Adverse reactions associated with ascorbic acid intake

• ascorbic acid decreases urine pH, which facilitates precipitation of urates, cystine or oxalates;
• ascorbic acid may interfere with the results of certain tests based on redox methods (e.g. determination of glucose or creatinine in blood and urine, faecal occult blood testing).

Adverse reactions associated with zinc intake

• nausea, vomiting, diarrhoea;
• headache.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Scorbolamid EXTRA

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures help protect the environment.

6. Contents of the pack and other information

What Scorbolamid EXTRA contains

• The active substances in the medicine are salicylamide, ascorbic acid, rutoside, and zinc. Each coated tablet contains 300 mg of salicylamide, 200 mg of ascorbic acid, 50 mg of rutoside, and 5 mg of zinc in the form of zinc gluconate.
• Other ingredients are: Tablet core – microcrystalline cellulose, crospovidone type B, hydroxypropyl cellulose, talc. Tablet coating I – Opadry White YS-1-7027: hypromellose 2910 (6 cP), triacetin, titanium dioxide (E 171); Tablet coating II – sucralose, Opadry Orange 85G33255: polyvinyl alcohol (E 1203), talc, macrogol 3350, titanium dioxide (E 171), brilliant blue FCF (E 110), tartrazine (E 102), soy lecithin (E 322).

What Scorbolamid EXTRA looks like and contents of the pack
Orange, round, biconvex coated tablets.
The pack contains 10, 20, or 30 coated tablets in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland
Tel. +48 22 364 61 01